This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation

Description

Training will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge.

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.

Areas Covered

-- The importance of technology transfer
-- The use of a technical review system to update and review technology knowledge obtained during drug product development
-- The use of a Product Strategy Review system to review important business aspects in preparation for transfer
-- Tools and Templates used for technology transfer

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.